Comparison Between Volatile Anesthetic-desflurane and Total Intravenous Anesthesia With Propofol and Remifentanil on Early Recovery Quality and Long Term Prognosis of Patients Undergoing Pancreatic Cancer and Common Bile Duct Cancer Surgery

Not Applicable

• Conditions: Pancreatic Cancer or Distal CBD Cancer
• Interventions: Drug: TIVA (Total intravenous anesthesia with propofol and remifentanil); Drug: Des (volatile anesthetic-desflurane)

• Registration Number: NCT03447691
• Lead Sponsor: Yonsei University

Brief Summary

Investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-27
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Patients with ASA class I-III who are scheduled to undergo general anesthesia and who are diagnosed with pancreatic cancer or common bile duct cancer and who are scheduled for PPPD or distal pancreatectomy
• patients who voluntarily agree to participate the clinical study after fully informed and understood about the study

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Exclusion Criteria

• there was distant metastasis at the time of diagnosis
• history of drug adverse reaction or use of opioid or sedative drugs before the surgery
• patients who can not communicate enough to answer the survey
• obesity patients over BMI 30
• patient who are expected to maintain ventilator care on the first day of post operation due to the difficult to extubation right after the surgery
• patients who have inappropriate reasons to participate in clinical research

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA Group	TIVA (Total intravenous anesthesia with propofol and remifentanil)	Propofol and remifentanil will be administered via intravenous, using an infusion pump capable of effect site target controlled infusion. TIVA Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate).
DES Group	Des (volatile anesthetic-desflurane)	Desflurane will be administered via tracheal intubation tube at the level of 0.7-1.1 MAC. Remifentanil will be maintained intravenously by continuous infusion rate of 0.01-0.1 mcg / kg / min DES Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate).

Primary Outcome Measures

Name	Time	Method
score of QoR40 (Quality of Recovery 40)	post operative day #3	The QoR-40 consists of a total of 40 questionnaires divided into five categories, it is considered to be the most appropriate index to measure the patient's integrated post operation recovery. Our primary outcome is the score of QoR-40 on the third day after surgery

Secondary Outcome Measures

Name	Time	Method
score of QoR40 (Quality of Recovery 40)	post operative day #7

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of